Transforming Clinical Trials with eSource: Scaling EHR2EDC and Harnessing Unstructured Data

• Explain how scaling EHR2EDC implementations improves data quality, workflow efficiency, and reduces site burden.
• Assess the potential of unstructured health data (notes, radiology, pathology, genomics) for regulatory-grade use through AI and NLP.
• Compare interoperability models, including hybrid FHIR–OMOP approaches, to ensure compliance, traceability, and scalability in eSource adoption.

ACDM members and non-members who would like to join an open discussion concerning a Hot Topic in Data Management.

This hot topic will explore the transformative role of eSource and EHR-to-EDC (EHR2EDC) integration in reshaping the future of clinical trials. Building on the work of the international eSource Task Force, the session will present real-world progress in scaling EHR2EDC implementations across hospitals and sponsors, highlighting measurable improvements in data quality, workflow efficiency, and site burden reduction. These experiences show how collaboration, interoperability standards, and effective change management are moving eSource adoption from pilot projects toward enterprise-level practice.

This hot topic will also draw on insights from an ongoing multi-stakeholder research study (to be published in Applied Clinical Trials, Q3 2025) that examines how unstructured health data—clinical notes, radiology, pathology, and genomics—can be activated for regulatory-grade use through AI and natural language processing. The study highlights both the opportunities and challenges of unlocking this 80% of health data that remains underutilized today, and identifies hybrid FHIR–OMOP models as a promising pathway to ensure traceability, compliance, and scalability.

Looking forward, the session will address the next frontiers of eSource. A central theme will be the potential to capture and manage adverse events directly through eSource workflows, reducing reliance on parallel reporting systems and strengthening patient safety data. In parallel, advances in agentic AI are opening the door to integrate unstructured EHR data into trial pipelines, expanding recruitment, refining eligibility, and enhancing trial efficiency.

The session will conclude with reflections on the organizational change required to fully realize these opportunities—emphasizing that technology alone is insufficient without governance, workforce adoption, and cross-stakeholder collaboration. Together, these developments signal a future where eSource becomes a cornerstone of faster, safer, and more inclusive clinical trials.